Special FDA designations for drug development : orphan, fast track, accelerated approval, priority review, and breakthrough therapy
Year of publication: |
2024
|
---|---|
Authors: | Michaeli, Daniel ; Michaeli, Christoph T. ; Albers, Sebastian ; Boch, Tobias ; Michaeli, Julia |
Published in: |
The European journal of health economics. - Berlin : Springer, ISSN 1618-7601, ZDB-ID 2011428-X. - Vol. 25.2024, 6, p. 979-997
|
Subject: | Accelerated approval | Breakthrough therapy | Clinical trial | Drug development | Drug price | Efficacy | European medicines agency | Fast track | Healthcare policy | Innovation | Orphan designation | Pharmaceutical policy | Priority review | Safety | Special designation | US food and drug administration | Arzneimittel | Pharmaceuticals | USA | United States | Pharmaindustrie | Pharmaceutical industry | Pharmakologie | Pharmacology | Arzneimittelrecht | Pharmaceutical law | Gesundheitspolitik | Health policy | EU-Staaten | EU countries | Technologiepolitik | Technology policy | Arzneimittelmarkt | Pharmaceutical market |
-
Hemphill, Thomas A., (2013)
-
R&D and market size : who benefits from orphan drug legislation?
Gamba, Simona, (2021)
-
Byrski, Dennis, (2021)
- More ...
-
Value drivers of development stage biopharma companies
Michaeli, Daniel, (2022)
-
Michaeli, Daniel T., (2022)
-
Kerka, Friedrich, (2013)
- More ...